MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PLUS PLASTIC SST TUBE; BLOOD COLLECTION TUBE

Catalog Number 367988

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during use of the bd vacutainer® plus plastic sst tube the ¿customer reported that while drawing a patient¿s blood the rubber stopper popped off of the tube and traveled across the room.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Medical device expiration date correction.The medical device expiration date field has been updated to reflect the corrected date of 11/30/2018.

Manufacturer Narrative

Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for stopper pop off with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for stopper pop off with the incident lot was observed.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Root cause description: a capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.Capa (b)(4).Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7354904
• MDR Text Key: 103036420
• Report Number: 1024879-2018-00106
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679886
• UDI-Public: 50382903679886
• Combination Product (y/n): N
• PMA/PMN Number: K050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 367988
• Device Lot Number: 7326737
• Date Manufacturer Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other